PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM— 510(k) K110456

Name: FDA 510(k) clearance K110456
Creator: U.S. Food and Drug Administration
Published: 2011-03-02

Substantially Equivalent

Pharmajet, Inc.

FDA 510(k) clearance K110456 for PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM, Substantially Equivalent on 2011-03-02. Applicant: Pharmajet, Inc.. Device class: 2.

Clearance details

Applicant: Pharmajet, Inc.
Product code: Code KZE
Device class: Class 2
Regulation: 21 CFR 880.5430
Advisory panel: General Hospital
Date received: 2011-02-16
Decision date: 2011-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden, CO, US

Download summary PDF View on FDA.gov ↗

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